FG-36UX FIBER ULTRASOUND GASTROSCOPE


Device Classification Name

endoscopic ultrasound system, gastroenterology-urology

510(k) Number K021276
Device Name FG-36UX FIBER ULTRASOUND GASTROSCOPE
Original Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 ramland rd.
orangeburg, 
NY 
10962

Original Contact paul silva
Regulation Number 876.1500
Classification Product Code
ODG  
Subsequent Product Code
ITX  
Date Received 04/22/2002
Decision Date 09/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No